Phase II Trial of Arsenic Trioxide in Relapsed and Refractory Acute Myeloid Leukemia, Secondary Leukemia, and/or Newly-Diagnosed Patients Greater Than or Equal to 65 Years Old

Trial Information

Phase II Trial of Arsenic Trioxide in Relapsed and Refractory Acute Myeloid Leukemia, Secondary Leukemia, and/or Newly-Diagnosed Patients Greater Than or Equal to 65 Years Old

OBJECTIVES: I. Determine the rate of response (complete or partial remission), duration of
response, relapse free survival, and overall survival of patients with relapsed or
refractory acute myeloid leukemia (AML) or untreated older patients or those with secondary
AML when treated with arsenic trioxide. II. Evaluate the toxicities of this agent in this
patient population. III. Measure degree of apoptosis induced and/or differentiation in
pretreatment and posttreatment AML cells.

OUTLINE: Patients receive arsenic trioxide IV over 1-4 hours daily for up to 60 days, or
until bone marrow blasts are less than 5%, followed by 4-6 weeks of rest. After the first
course, additional courses of arsenic trioxide last 25 days. Treatment continues for a
maximum of 6 courses in the absence of unacceptable toxicity or disease progression.
Patients with a complete response (CR) receive 1 additional 25 day course after achieving
CR. Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months
for 12 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Documented acute myelogenous leukemia (AML) including secondary
AML and biphenotypic leukemia Secondary AML may be either chemotherapy induced or evolving
from a myelodysplastic syndrome Bone marrow evidence of AML must include the following:
Cellularity of 20% or greater Minimum of 20% leukemic cells Signs of bone marrow failure
such as: Anemia (hemoglobin less than 12.0 g/dL) Granulocytopenia (granulocyte count less
than 1,500/mm3) Thrombocytopenia (platelet count less than 100,000/mm3) Must not be any of
the following: Acute lymphoblastic leukemia Blastic phase of chronic myelogenous leukemia
Acute promyelocytic leukemia (M3) Prior induction therapy using any conventional induction
chemotherapy regimen required In first or second relapse after successful induction
therapy OR Failed 1 attempt at reinduction relapse OR Refractory to at least 1 prior
induction therapy No prior induction therapy allowed in secondary AML or in newly
diagnosed AML in patients at least 65 years old

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At
least 6 weeks Hematopoietic: See Disease Characteristics No evidence of being platelet
transfusion refractory WBC no greater than 20,000/mm3 (leukapheresis, hydroxyurea, or both
allowed) Hepatic: Bilirubin no greater than 2.0 mg/dL unless leukemic infiltration to
liver SGOT or SGPT less than 2 times upper limit of normal Renal: Creatinine no greater
than 2.0 mg/dL Cardiovascular: No evidence of symptomatic coronary atherosclerotic heart
disease Other: Not pregnant Negative pregnancy test Fertile patients must use effective
contraception No active infection and afebrile Afebrile, stable, and completing
antibiotics allowed Febrile not from infection but from blood products allowed

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